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Completed

NCT Number: NCT00853710

Test Semiquantitative Prostate Specific Antigen (PSA)

The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Rene Huguenin

Saint-Cloud, 92210, France

About this study

Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
  • Patients must have given informed consent.

Exclusion criteria

  • Patients followed for a disease other than prostatic.

Treatment and study plan

PSA assay

Other

rapid prostate specific antigen assay.

Primary outcomes

  1. Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.

    Time frame: day of test

Secondary outcomes

  1. Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.

    Time frame: at the last inclusion

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

Validation of a Semiquantitative Screening Assay for PSA

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 2, 2009
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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